6EN-37789-13212

2 vaccinations 8 coded responses 23 check-ins 8 free-text entries 3 call cases

Sex: Female
Age at first dose: 56-60
ZIP prefix: 751 / TX
Registered: 2021-02-24

Relationship: Self
Race: White
Ethnicity: Not Hispanic or Latino

Timeline

Registration Vaccinations Survey responses Call reports Cases without a report Call attempts Call successful Pregnancy survey

2021-02-24
Registered in v-safe
2021-02-24
Dose 1 — Pfizer-BioNTech
2021-02-24
Health check-in — day 0, dose 1
Feeling: Good · Site: Pain · Headache, Nausea

Adult check-in
2021-02-25
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · Headache, Nausea

Adult check-in
2021-02-26
Survey response — days 1–6 daily, dose 1
MedDRA: Malaise, Pre-existing disease, Urine abnormality — Feeling: Poor · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Vomiting, Abdominal pain · Be unable to do your normal daily activities

Free text: To be fair I dont think my symptoms are related to the shot. I went my doctor and had very cloudy urine. Im a double Ostomy cancer prevailer which is probably the culprit of me getting sick, but I still think its important to let yall know what my body is doing.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-28
Survey response — days 1–6 daily, dose 1
MedDRA: Kidney infection, Pre-existing disease — Feeling: Fair · Headache, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Im reporting these symptoms but still think they are related to my Ostomy condition which caused me to have another kidney infection. But still think its important for yall to know, since I got the shot on a Wednesday and by early like around 3am this happened.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-01
Survey response — days 1–6 daily, dose 1
MedDRA: Unevaluable event — Feeling: Fair · Muscle or body aches, Fatigue or tiredness, Nausea

Free text: Still think this is not vaccine related, but think yall should know this information

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-02
Survey response — days 1–6 daily, dose 1
MedDRA: Adverse reaction — Feeling: Fair · Fatigue or tiredness

Free text: Still think this is connected to my Ostomy bags and the way it hit me suddenly, but still think yall need to know this information.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-05
Health check-in — day 7, dose 1
Feeling: Good · None

Adult check-in
2021-03-10
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-03-17
Dose 2 — Pfizer-BioNTech
2021-03-17
Health check-in — day 0, dose 2
Feeling: Good · Site: Pain · Headache, Joint pains, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-03-19
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Itching · Headache, Joint pains, Fatigue or tiredness

Adult check-in
2021-03-20
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-03-21
Survey response — days 1–6 daily, dose 2
MedDRA: Flank pain, Vaccine positive rechallenge — Feeling: Good · Site: Pain · Joint pains, Muscle or body aches, Fatigue or tiredness

Free text: As an Ostomy patient with a colostomy and Urostomy I felt same pain on right side as first vaccine shot. Also seems to have affected my output both times.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-22
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-03-23
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · Fatigue or tiredness

Adult check-in
2021-03-24
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-04-02
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-04-09
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-04-16
Survey response — day 28, dose 2
MedDRA: Hospitalisation, Urinary tract infection — Feeling: Poor · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Emergency room or emergency department visit

Free text: Has nothing to do with covid. Ended up in the hospital due to severe UTI.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-16
Report sent to call center — day 28, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-04-21
Health check-in — day 35, dose 2
Feeling: Fair

Adult check-in
2021-04-28
Survey response — day 42, dose 2
MedDRA: Emergency care, Sepsis, Urinary tract infection — Feeling: Good · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Emergency room or emergency department visit

Free text: Ended up in ER with a severe UTI that was turning into sepsis. Not Covid or vaccine related though.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-28
Report sent to call center — day 42, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-06-16
Survey response — 3 months, dose 2
MedDRA: Emergency care, Infection, Unevaluable event — Feeling: Good · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Emergency room or emergency department visit

Free text: Nothing connected to Covid. I had a severe infection that landed me in the ER.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-16
Report sent to call center — 3 months, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-06-25
Call 1 — Left Voicemail
2021-09-15
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2022-03-17
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-02-24	Pfizer-BioNTech
2	2021-03-17	Pfizer-BioNTech

Call center

3 call center cases

3 unsuccessful

See the call center timeline

Free text

Release 4 — days 1–6 daily, dose 1

2021-02-26

Systemic reaction (other): To be fair I dont think my symptoms are related to the shot. I went my doctor and had very cloudy urine. Im a double Ostomy cancer prevailer which is probably the culprit of me getting sick, but I still think its important to let yall know what my body is doing.

2021-02-28

Systemic reaction (other): Im reporting these symptoms but still think they are related to my Ostomy condition which caused me to have another kidney infection. But still think its important for yall to know, since I got the shot on a Wednesday and by early like around 3am this happened.

2021-03-01

Systemic reaction (other): Still think this is not vaccine related, but think yall should know this information

2021-03-02

Systemic reaction (other): Still think this is connected to my Ostomy bags and the way it hit me suddenly, but still think yall need to know this information.

Release 6 — days 1–6 daily, dose 2

2021-03-21

Systemic reaction (other): As an Ostomy patient with a colostomy and Urostomy I felt same pain on right side as first vaccine shot. Also seems to have affected my output both times.

Release 7 — day 28, dose 2

2021-04-16

Symptoms: Has nothing to do with covid. Ended up in the hospital due to severe UTI.

Release 8 — day 42, dose 2

2021-04-28

Symptoms: Ended up in ER with a severe UTI that was turning into sepsis. Not Covid or vaccine related though.

Release 9 — 3 months, dose 2

2021-06-16

Symptoms: Nothing connected to Covid. I had a severe infection that landed me in the ER.

Each entry is dated by the survey it was written in (the CDC re-sent the releases with survey dates in 2025); click a date to see that survey response. The CDC cut some text off at about 250 characters: symptoms in every release, and the other two fields in releases 9-12. Those entries are marked "cut off by CDC".

MedDRA terms by release

Field	Preferred term	2021-09	2023-04	2024-11
SD	Emergency care	✓	✓	✓
SD	Hospitalisation	✓	✓	✓
SD	Infection	✓	·	✓
SD	Sepsis	✓	✓	✓
SD	Unevaluable event	○	✓	○
SD	Urinary tract infection	✓	✓	✓
SRO	Adverse reaction	✓	✓	✓
SRO	Flank pain	✓	✓	✓
SRO	Kidney infection	✓	✓	✓
SRO	Malaise	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Unevaluable event	✓	✓	✓
SRO	Urine abnormality	✓	✓	✓
SRO	Vaccine positive rechallenge	✓	✓	✓

✓ active code · ○ coded but marked inactive · blank = not in that release